Erythromycin

Product NDC
62332-397
11-digit product format
623320397
Labeler code
62332
Product ID
62332-397_b4e8041f-a6b6-4f91-afad-74183c368d3c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Erythromycin
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Alembic Pharmaceuticals Inc.
Application
ANDA215661
Marketing category
ANDA
Marketing start
2023-08-28
Substance
ERYTHROMYCIN
Active strength
250 mg/1
Pharmacologic classes
Decreased Sebaceous Gland Activity [PE], Macrolide Antimicrobial [EPC], Macrolide [EPC], Macrolides [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Erythromycin
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ERYTHROMYCIN250 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii63937KV33D
Rxcui197650, 598006

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d329c2e1-5ae8-4e64-aea0-77ecea3fa1abProduct name320250717
3b331500-3b74-bd2b-fede-d46839f2f4d5Product name620240313
fdae2630-eae0-4769-abfd-8f33d5b771b4Product name320240202
8c898317-b543-1e4e-254f-84cec2f3f57eProduct name220191002
64ae94c0-3212-d73a-92da-9e6dd85c6ebeProduct name220180118
edcfa1cf-915f-1a4c-d0aa-508cc66e70d9Product name220170816
ad75fcfd-a339-42a1-9c60-43ba2c654cfaProduct name120170810
57850177-5927-151f-e1fa-7e2ca47f81e5Product name120140508
8ee71591-1d8f-e24e-242b-bfef131e3168Product name120140508
bff5cf99-0f45-fa15-2a76-b160c3c4cc3cProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
62332-397-30Erythromycin30 in 1 BOTTLETABLET, FILM COATED303
62332-397-31Erythromycin100 in 1 BOTTLETABLET, FILM COATED1003
62332-397-91Erythromycin1000 in 1 BOTTLETABLET, FILM COATED10003

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62332-397ERYTHROMYCIN TABLET, FILM COATED [ALEMBIC PHARMACEUTICALS INC.]3Current NDC, 3 package rows20230829_383f9011-a3e0-4d7d-b058-5f8ab319dc8c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
598006erythromycin 250 MG Oral TabletPSN383f9011-a3e0-4d7d-b058-5f8ab319dc8c3
197650erythromycin 500 MG Oral TabletPSN383f9011-a3e0-4d7d-b058-5f8ab319dc8c3
598006erythromycin 250 MG Oral TabletSCD383f9011-a3e0-4d7d-b058-5f8ab319dc8c3
197650erythromycin 500 MG Oral TabletSCD383f9011-a3e0-4d7d-b058-5f8ab319dc8c3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
62332-397-306233203973030 TABLET, FILM COATED in 1 BOTTLE (62332-397-30) 2023-08-28NoNoCurrent
62332-397-3162332039731100 TABLET, FILM COATED in 1 BOTTLE (62332-397-31) 2023-08-28NoNoCurrent
62332-397-91623320397911000 TABLET, FILM COATED in 1 BOTTLE (62332-397-91) 2023-08-28NoNoCurrent